CTSN Embolic Protection Trial

What this study is about

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

Who can join (things the study team will check)

✅ You may be able to join if…

• Age ≥ 60 years
• Planned de novo or redo:
  • Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
  • Mitral valve replacement (MVR) ± CABG
  • Mitral Valve Repair + CABG,
  • Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure.
  • Valve sparing aortic root replacement (David procedure)
  • Valve sparing aortic root replacement (David procedure)
• No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization
• Ability to provide informed consent and comply with the protocol

🚫 You may not be able to join if…

• History of clinical stroke within 3 months prior to randomization
• Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
• Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening/baseline NIHSS score conducted prior to the catheterization
• Active endocarditis at time of randomization with vegetation criteria
• Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
• Participation in an interventional (drug or device) trial
• Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
• Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
• Planned concomitant carotid endarterectomy during index surgical procedure

Where this trial is running

• CHI St. Vincent Heart Institute, North Little Rock, Arkansas, United States
• Keck Hospital of the University of Southern California, Los Angeles, California, United States
• Emory University, Atlanta, Georgia, United States
• Indiana University, Bloomington, Indiana, United States
• Indiana Ohio Heart, Fort Wayne, Indiana, United States
• Ochsner Clinic, New Orleans, Louisiana, United States
• Maine Medical Center, Portland, Maine, United States
• Johns Hopkins Medicine, Baltimore, Maryland, United States
• University of Maryland, College Park, Maryland, United States
• Massachusetts General Hospital, Boston, Massachusetts, United States
• University of Michigan, Ann Arbor, Michigan, United States
• Mayo Clinic, Rochester, Minnesota, United States

+ 16 more sites.

Who to contact

Claudia Merlin · 917-494-2387 · Claudia.merlin@mountsinai.org

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06027788.